Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000247673p
Ethics application status
Submitted, not yet approved
Date submitted
22/02/2023
Date registered
8/03/2023
Date last updated
8/03/2023
Date data sharing statement initially provided
8/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A rinse or a drink? An exploration of blackcurrant juice-mediated MAO-B inhibition
Scientific title
Investigating the differential effects between a blackcurrant oral-rinse and ingested drink on platelet MAO-B activity, circulating metabolites, cognition and mood in healthy adults.
Secondary ID [1] 308575 0
Nil known
Universal Trial Number (UTN)
U1111-1284-9842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive stress & support 329037 0
Condition category
Condition code
Neurological 326017 326017 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, placebo-controlled, cross-over design intervention study which aims to characterise temporal platelet monoamine oxidase-B (MAO-B) activity immediately following blackcurrant juice ingestion and oral rinsing. Furthermore, subjective changes in mood, blood glucose, and cognitive performance will be assessed following blackcurrant ingestion and oral rinse, and putative metabolites associated with MAO-B inhibition identified. Prospective participants who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s trial coordinator. During this session, the study’s trial coordinator and the principal investigator will explain the logistics of the trial to them and introduce them to the visual analogue scales for mood and mental fatigue that they will be asked to complete to during their test sessions. Participants will also be instructed on how to complete the five cognitive tasks that will make up the cognitive battery that they will undergo during their test sessions. These tasks are word recall, digit vigilance, Stroop, rapid visual information processing and logical reasoning. This familiarisation session will last approximately 30 minutes.

Participants will be given a list of foods (e.g. berry-derived foods, anthocyanin-rich foods) to abstain from consuming 24 hours before each trial day. Participants will be randomly allocated into one of the two intervention groups: oral rinse or ingested drink, at a ratio of 1:1. The participants will be randomly assigned the order in which they will receive the two treatments: blackcurrant and placebo, 1:1. The oral rinse treatment will be: (1) 225 mL water followed by mouth-rinsing with 25 mL blackcurrant solution for 1 minute and (2) 225 mL of water followed by mouth-rinsing with 25 mL placebo solution for 1 minute. The ingestion group will be: (1) 25 mL of blackcurrant solution followed by 225 mL of water and (2) 25 mL of placebo solution followed by 225 mL of water.

On the first day of the allocated trial arm, participants will arrive at the research facility to complete a test session to assess the effects of their allocated intervention on their MAO-B activity, mood and cognitive function. A person trained in cannulation and venepuncture will insert a venous cannula into a peripheral vein of the arm of the participant to collect blood samples across multiple times points. Before each blood sample, the participant's mood, stress, anxiety and mental fatigue will be assessed using Bond-Lader and visual analogue scales (VAS). Approximately fifteen minutes after the first blood sample, participants will receive their allocated intervention. The intervention will be served in a small opaque white vessel. Seven blood samples will be collected (~10mL each) beginning on arrival and 2, 5, 10, 20, 60, 120-140 min post-intervention. Research staff will be present throughout the study period to ensure adherence to protocol.

After the 60 min blood sample, participants will undergo the cognitive battery. After this battery, there will be a final mood assessment and a blood sample will be collected. Participants will be provided with snacks and allowed to leave the facility. Approximately one week after this first visit, participants will be scheduled to come into the research facility and complete the same trial as above, consuming the other intervention they did not consume in the first session.
Intervention code [1] 325444 0
Treatment: Other
Comparator / control treatment
The placebo beverage will contain similar amounts of sugars to the blackcurrant intervention. The placebo drink will also be colour matched and flavoured with commercial blackcurrant flavouring and food acids to be as similar in flavour as possible to the blackcurrant intervention. The placebo for the oral rinse and ingested drink will be the same,
Control group
Placebo

Outcomes
Primary outcome [1] 333312 0
Changes in Platelet monoamine oxidase-B activity (MAO-B) using a commercial assay kit.
Timepoint [1] 333312 0
MAO-B enzyme activity will be measured in platelet samples isolated from whole blood and will be analysed using a commercial assay kit. At each visit, seven blood samples will be collected. Samples collected will include baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [1] 416590 0
Untargeted multi-omic analysis of plasma samples using validated Liquid chromatography-mass spectrometry (LC-MS) techniques - exploratory outcome
Timepoint [1] 416590 0
At each visit, seven blood samples will be collected. Samples collected will include baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [2] 418596 0
Subjective measures of mood using a Bond-Lader Visual Analogue questionnaire
Timepoint [2] 418596 0
The Bond-Lader Visual Analogue questionnaire comprises of 16 mood descriptors that correspond with three mood factors: alert, calm and content. Mood survey will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [3] 418597 0
Stress using a Visual Analogue Scale
Timepoint [3] 418597 0
Visual Analogue Scale will be anchored at “not at all” on the left hand side of the scale and “extremely” on the right, with higher scores representing more stress/anxiety/mental fatigue/higher difficulty. These assessments will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [4] 418599 0
Composite measures of cognitive function parameters will include attention, reaction time, cognitive flexibility, working memory and learning using Computerised Mental Performance Assessment System (COMPASS)
Timepoint [4] 418599 0
This will be conducted 60 min post-intervention and last approximately 60 min.
Secondary outcome [5] 419070 0
Anxiety using a Visual Analogue Scale
Timepoint [5] 419070 0
Visual Analogue Scale will be anchored at “not at all” on the left hand side of the scale and “extremely” on the right, with higher scores representing more stress/anxiety/mental fatigue/higher difficulty. These assessments will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [6] 419071 0
Mental fatigue using a Visual Analogue Scale
Timepoint [6] 419071 0
Visual Analogue Scale will be anchored at “not at all” on the left hand side of the scale and “extremely” on the right, with higher scores representing more stress/anxiety/mental fatigue/higher difficulty. These assessments will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [7] 419079 0
Sick/Nausea using a Visual Analogue Scale
Timepoint [7] 419079 0
Visual Analogue Scale will be anchored at “not at all” on the left hand side of the scale and “extremely” on the right, with higher scores representing more stress/anxiety/mental fatigue/higher difficulty. These assessments will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.
Secondary outcome [8] 419080 0
Discomfort/Cramps using a Visual Analogue Scale
Timepoint [8] 419080 0
Visual Analogue Scale will be anchored at “not at all” on the left hand side of the scale and “extremely” on the right, with higher scores representing more stress/anxiety/mental fatigue/higher difficulty. These assessments will be completed at baseline upon arrival at the laboratory and 2, 5, 10, 20, 60 min post-intervention and at the completion of the cognitive test.

Eligibility
Key inclusion criteria
Healthy individual (male or female) 18 – 45 years, BMI between 18-30kg/m2 who are able to provide written consent to participate when selected for this study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling or unable to provide written consent or comply with the study procedures. Participants will also be excluded if they have known hypersensitivity or intolerance to blackcurrants or food products derived from these ingredients. In addition, participants will be excluded if they are pregnant, planning to get pregnant in the immediate future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) recent bacterial/viral illness or taken antibiotics, (iii) are taking medication that affects the properties of blood (e.g. blood clotting) or immune function, (iv) history of gastrointestinal disorders, (v) chronic/psychiatric conditions, (vi)being on controlled diet and have had significant weight loss in previous six month, (vii) excessive alcohol intake (>21 drinks a week), (viii) aversion to blood sampling, (ix) are a current smoker/vaper,(x). unable to complete the cognitive tasks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a double-blind, placebo-controlled, cross-over design intervention study consisting of two treatment interventions. In the first arm of this study, participants will be randomly allocated evenly to the two treatment groups (blackcurrant and placebo). The randomisation of participants will be undertaken by a fellow scientist not involved in this study using a computer randomisation function. In the second arm of the study, participants will be assigned the treatment intervention they did not receive in the first arm. All recruited participants will then be allocated a random participant code (consisting of numerical and alphabetical characters) containing no information on which order of treatment they were allocated to. To conceal the treatment allocation from the study investigators, those preparing and packaging the treatment interventions for the participants will not be involved in any other study component. A dose of each intervention will be packaged in opaque drink bottles. These measures will be taken to conceal the identity of the interventions from the volunteers and study investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a double-blind, placebo-controlled, parallel crossover study. Participants will be evenly randomly allocated into two treatment groups: blackcurrant and placebo. The randomisation of participant treatment allocation for each participant will be undertaken by a fellow scientist not involved in this study using the randomisation function in Microsoft Excel. The key to participant treatment allocation will be until the trial and data analysis is completed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
All study data will be captured on study specific worksheets and transcribed to an access-restricted database maintained by PFR. Analysed data will be presented as mean values and standard errors of the mean. Statistical significance for the comparison between timepoints and treatment groups will be assessed using Student’s t-tests. Where multiple comparisons are required, a two-way ANOVA mixed design will be applied. Statistical significance for all indices will be set at P < 0.05 with a confidence level of 95%. Correlation analysis between subjective and objective measures will also be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
Date of last participant enrolment
Anticipated
7/08/2023
Actual
Date of last data collection
Anticipated
2/10/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 25171 0
New Zealand
State/province [1] 25171 0
Manawatu

Funding & Sponsors
Funding source category [1] 312823 0
Government body
Name [1] 312823 0
The New Zealand Institute for Plant & Food Research Ltd.
Country [1] 312823 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road,
Fitzherbert,
Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 314932 0
None
Name [1] 314932 0
Address [1] 314932 0
Country [1] 314932 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312102 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 312102 0
Ethics committee country [1] 312102 0
New Zealand
Date submitted for ethics approval [1] 312102 0
21/02/2023
Approval date [1] 312102 0
Ethics approval number [1] 312102 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123482 0
Miss Nayer Ngametua
Address 123482 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 123482 0
New Zealand
Phone 123482 0
+64 6 355 6230
Fax 123482 0
+64 6 351 7050
Email 123482 0
[email protected]
Contact person for public queries
Name 123483 0
Alexander Kanon
Address 123483 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 123483 0
New Zealand
Phone 123483 0
+64 6 953 7706
Fax 123483 0
+64 6 351 7050
Email 123483 0
[email protected]
Contact person for scientific queries
Name 123484 0
Dominic Lomiwes
Address 123484 0
The New Zealand Institute for Plant & Food Research Ltd.
Batchelar Road
Private Bag 11600
Palmerston North 4442
Country 123484 0
New Zealand
Phone 123484 0
+64 6 355 6113
Fax 123484 0
+64 6 351 7050
Email 123484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics requirements for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study. Furthermore, has potential commercial outcomes and publicly disclosing participant data will jeopardise the company's ability to protect the intellectual property generated from this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.